Chronic Obstructive Pulmonary DiseaseNCT01825538
Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Fibrosis, run by Jennifer McCallister MD at 1 site in United States.
Trial summary
To understand current practices of pulmonary physicians in relation to Advanced Care Planning (ACP) in order to develop future disease-specific tools that will improve patient-physician communication about ACP. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD or pulmonary fibrosis
Who may be able to join
- Patients who are between 18 and 88 years of age who have been diagnosed with a physician diagnosis of COPD based on at least one of the following:
- clinical history - a documented history of COPD, emphysema, or chronic bronchitis.
- pulmonary function results - defined as an forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) less than 0.7
- Patients who are between 18 and 88 years of age and have been diagnosed with pulmonary fibrosis based on the following:
- Subpleural, basal predominance of parenchymal abnormality on high resolution computed tomography (HRCT)
- Reticular abnormality on HRCT
Show all 9Show fewer
- Honeycombing without traction bronchiectasis on HRCT
- Absence of features that are inconsistent with usual interstitial pneumonia (UIP) pattern OR
- UIP based on surgical lung biopsy
Who cannot join
- Age < 18 years or > 88 years
- Prisoners
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
To understand current practices of pulmonary physicians in relation to Advanced Care Planning (ACP) in order to develop future disease-specific tools that will improve patient-physician communication about ACP.
Read the detailed description
The study will be a retrospective, observational study and analysis of charts of patients with Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis treated as outpatients at the Ohio State University Wexner Medical Center Lung Center. Using pre-existing data, we will determine if advanced care planning has been discussed with these patients and record this information. For all patients, we will gather data about specific demographic and clinical characteristics that may have contributed to the presence or absence of these discussions. The study is descriptive in nature and is not powered to detect a difference between the two groups. Instead, we aim to describe the characteristics most frequently associated with advanced care planning discussion in these two particular groups.
Potential subjects will be identified with assistance from the Information Warehouse. After identification, data will be abstracted from pre-existing data in the electronic medical record and collected in a coded fashion for each subject. Each subject will be assigned an anonymous subject identification number and all links to identifying information will be destroyed prior to analysis. All study data will be stored on a secure password protected data base to which only study personnel will have access.
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary fibrosis, Advanced care planning
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD, pulmonary fibrosis | observational study, no interventions to be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease
This is a descriptive study which will retrospectively review whether Advanced Care Planning discussions have been documented in the medical records of patients with chronic obstructive pulmonary disease or pulmonary fibrosis. Using pre-existing data, we will determine if Advanced Care Planning has been discussed with these patients and record this information.
Measured: Last two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer McCallister MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer McCallister MD, Ohio State University
- Investigators
- Jennifer W McCallister, M.D, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825538
- Sponsor's protocol ID
- 2012H0435
- Status last verified
- Jul 2014
- First submitted
- 21 Mar 2013
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT01825538
- Acronym / sponsor ID
- 2012H0435
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary fibrosis, Advanced care planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Jennifer McCallister MDUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand current practices of pulmonary physicians in relation to Advanced Care Planning (ACP) in order to develop future disease-specific tools that will improve patient-physician communication about ACP.
Detailed description
The study will be a retrospective, observational study and analysis of charts of patients with Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis treated as outpatients at the Ohio State University Wexner Medical Center Lung Center. Using pre-existing data, we will determine if advanced care planning has been discussed with these patients and record this information. For all patients, we will gather data about specific demographic and clinical characteristics that may have contributed to the presence or absence of these discussions. The study is descriptive in nature and is not powered to detect a difference between the two groups. Instead, we aim to describe the characteristics most frequently associated with advanced care planning discussion in these two particular groups.
Potential subjects will be identified with assistance from the Information Warehouse. After identification, data will be abstracted from pre-existing data in the electronic medical record and collected in a coded fashion for each subject. Each subject will be assigned an anonymous subject identification number and all links to identifying information will be destroyed prior to analysis. All study data will be stored on a secure password protected data base to which only study personnel will have access.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD, pulmonary fibrosis | – | –observational study, no interventions to be administered |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD or pulmonary fibrosis
Key inclusion criteria (9 listed)
- Patients who are between 18 and 88 years of age who have been diagnosed with a physician diagnosis of COPD based on at least one of the following:
- Patients who are between 18 and 88 years of age and have been diagnosed with pulmonary fibrosis based on the following:
Key exclusion criteria (3 listed)
- Age < 18 years or > 88 years
- Prisoners
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease
Time frame: Last two years
This is a descriptive study which will retrospectively review whether Advanced Care Planning discussions have been documented in the medical records of patients with chronic obstructive pulmonary disease or pulmonary fibrosis. Using pre-existing data, we will determine if Advanced Care Planning has been discussed with these patients and record this information.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer W McCallister, M.D principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Fibrosis, run by Jennifer McCallister MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record the presence or absence of Advanced Care Planning (ACP) discussions with patients with advanced lung disease (time frame: Last two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.